1. When does the IRB require fully translated consent? For example, after the Short Form is used?
2. Does any IRB require certification of the translation or permit translations only from certain qualified organizations?
3. Does any IRB require/recommend the witness be impartial? What kind of guidance do they provide for this?

Thank you!

1. How are other institutions meeting the witness requirement?
2. Is anyone proactively resourcing alternative witnesses when the interpreter does not wish to serve as a witness and will not sign as such on the ICF?
3. Are there issues with interpreters agreeing to sign as a witness and what kind of guidance does IRB give?

Thanks! 

Thank you.

I have a quick question to ask about REDCap eConsent in preparation for a Friday afternoon meeting.  I hope your responses can help our group make some decisions about keeping a current process or making some changes.

Our HRPP policies require that non-exempt research that doesn’t have a waiver of documentation approved will require signing the IRB-approved, stamped consent form.  For REDCap consent this means that subjects sign within a REDCap project that includes scrolling through a PDF of the IRB approved stamped consent form.  The signatures, and any checkboxes are then completed via the signatures within REDCap, per the REDCap eConsent platform.

I’d like to get a sense of how many institutions follow a similar requirement to use the PDF of the stamped consent form pages, and conversely, how many allow the consent language to be typed into REDCap.  And for the latter method, is there anything further information you can provide regarding ensuring that the consent language typed into REDCap is in fact the IRB-approved language?

Thank you!

Mary-Tara

___________________________________________________

Mary-Tara Roth, RN, MSN, MPH

Director, Clinical Research Resources Office

Boston University Medical Campus/Boston Medical Center

72 East Concord Street, Evans 708

Boston, MA 02118

617-358-7679 (ph)

mtroth@bu.edu